Recall Z-0010-2018 ยท HLI Ophthalmoscope, Ac-Powered
Optovue, Inc.
iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue 500 with normati
| Date | Jul 27, 2017 |
| Status | Terminated |
| Reason | FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). |
| Root cause | Other |
| Action | Optovue sent an Urgent Medical Device Software Field Correction letter dated July 27, 2017, via FedEx mail. Customers were Instructed to discontinue use of the Vault Mapping software, to complete and return the recall response form, and to provide remote access to units to an Optovue representative so that new software can be downloaded remotely. Questions can be addressed by calling Optovue at 1-866-941-9240. |
| Quantity | 326 devices |
| Distribution | US Nationwide Distribution in the states of - AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, & WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133892 | IVUE 500 Optovue, Inc., Mar 19, 2014 |